21 results
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24ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Microlife Upper Arm Automatic Digital Blood Pressure Monitor, Model BP3MW1-4Y
FDA 510(k)
FDA Class 2
·Cardiovascular
BD MAX¿ ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·December 6, 2023
VALVED TEARAWAY INTRODUCER GENERATION II
FDA 510(k)
FDA Class 2
·Cardiovascular
MYOSURE XL TISSUE REMOVAL DEVICE (1 PACK) MYOSURE XL TISSUE REMOVAL DEVICE (3 PACK)
FDA 510(k)
FDA Class 2
·Obstetrics/Gynecology
BD MAX¿ ENTERIC BACTERIAL PANEL
FDA Adverse Event
Malfunction
·GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS)·Product code PCI·December 6, 2023
CODA BALLOON CATHETER
FDA Adverse Event
Injury
·COOK INC·Product code DQY·April 4, 2019
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 11, 2026
OBTRYX SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·June 17, 2013
ACCESS® 2 IMMUNOASSAY SYSTEM
FDA Adverse Event
Injury
·BECKMAN COULTER, INC.·Product code MMI·July 22, 2011
MOBILE INFANT WARMER
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE, LTD.·Product code FMT·September 19, 2008
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·May 22, 2025
REFOBACIN BONE CEMENT R 1X40-3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 18, 2025
OPTIPAC 80 BIOMET BC R
FDA Adverse Event
Death
·BIOMET FRANCE S.A.R.L.·Product code LOD·April 9, 2026
BIOMET BONE CEMENT R 40 -3
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·July 31, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·June 17, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
OPTIPAC 60 REFOB BONE CMT R-3
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·February 5, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Injury
·BIOMET FRANCE S.A.R.L.·Product code LOD·October 8, 2025
BIOMET BONE CMENT R 1X40 JP
FDA Adverse Event
Malfunction
·BIOMET FRANCE S.A.R.L.·Product code LOD·April 8, 2025